OncoMatch/Clinical Trials/NCT03509961
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Is NCT03509961 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Myeloablative allogeneic HCT with a non-TBI conditioning regimen for b-cell acute lymphoblastic leukemia.
Treatment: Myeloablative allogeneic HCT with a non-TBI conditioning regimen — This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Disease stage
Required: Stage CR1, CR2, CR3
Prior therapy
Must have received: blinatumomab (blinatumomab) — CR1 or CR2
Patients in CR1 or CR2 after blinatumomab treatment.
Must have received: CAR-T cell therapy — CR1 or CR2
Patients in CR1 or CR2 after CAR-T cellular therapy.
Cannot have received: inotuzumab ozogamicin (inotuzumab ozogamicin)
Exception: allowed for observational arm only
Patients who have received inotuzumab treatment prior to allogeneic HCT are NOT eligible for the study treatment arm. All inotuzumab-treated patients are eligible for the observational arm.
Cannot have received: allogeneic hematopoietic stem cell transplant
No prior allogeneic hematopoietic stem cell transplant.
Lab requirements
Kidney function
Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or a serum creatinine based on age/gender.
Liver function
SGOT (AST) or SGPT (ALT) < 5 x ULN for age. Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
Cardiac function
Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care.
Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as: Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen. Renal: Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or a serum creatinine based on age/gender. Cardiac: Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care. Hepatic: SGOT (AST) or SGPT (ALT) < 5 x upper limit of normal (ULN) for age. Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's of Alabama/University of Alabama in Birmingham(UAB) · Birmingham, Alabama
- Phoenix Children's Hospital · Phoenix, Arizona
- City of Hope · Duarte, California
- Children's Hospital Los Angeles · Los Angeles, California
- UCLA Mattel Children's Hospital · Los Angeles, California
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